Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment

Recruiting now · Phase 4

Conditions studied: Helicobacter Pylori

In brief

This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1.

Key facts

Study ID

NCT07122024

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

414

Starts

2024-02-19

Expected to finish

2025-12-30

Last updated by the study team

2025-08-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients aged 18 to 65 years old, regardless of gender;
• H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H\&E staining or bacterial culture;
• No previous history of H. pylori eradication therapy;
• Subjects able to independently complete the recording of the subject diary card;
• Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form.

You may not qualify if…

• Use of acid-suppressing drugs such as proton pump inhibitors (PPIs), potassium-competitive acid blocker (P-CAB), H2 receptor antagonists, etc., within 2 weeks before enrollment, or use of antibiotics within 4 weeks before enrollment;
• Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.;
• Previous history of esophageal or gastric surgery;
• Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases;
• Participants with allergies or hypersensitivity to keverprazan, rabeprazole, amoxicillin, clarithromycin, bismuth agents, including its excipients (such as mannitol, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, etc.);
• Female participants who are pregnant, breastfeeding;
• Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events;
• Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators;
• Deemed unsuitable for participation in the study by the investigator for any other reason.

Where it is running

• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.